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RECRUITING
NCT06839898
NA

A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses

Sponsor: Biotech Healthcare Holding Gmbh

View on ClinicalTrials.gov

Summary

Primary Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Secondary Objectives: To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism.

Official title: A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses to Compare Outcomes in Patients With Moderate to High Myopia and Astigmatism

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

172

Start Date

2021-10-10

Completion Date

2027-02

Last Updated

2025-02-21

Healthy Volunteers

No

Interventions

DEVICE

EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm

The patients will be implanted with Eyecryl Phakic IOL at this arm based on randomization.Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.

DEVICE

Visian® Toric ICL Treatment Arm

The patients will be implanted with Visian® Toric Implantable Contact Lens at this arm based on randomization. Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.

Locations (4)

Precise Vision Augentagesklinik Greven

Münster, North Rhine-Westphalia, Germany

Precise Vision Augentagesklinik Rheine

Rheine, North Rhine-Westphalia, Germany

Precise Vision Augentagesklinik Rheine

Steinfurt, North Rhine-Westphalia, Germany

Netradhama Superspeciality Eye Hospital

Bangalore, Karnataka, India